DiabetesPhase 3SUSTAIN 9NCT03086330
Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus
A Phase 3 study testing Semaglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 72 sites in 7 countries.
Trial summary
This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 302 participants
- Where
- 72 sitesin 7 countries
- Study dates
- 15 Mar 2017to 6 Aug 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- Male or female, above or equal to 18 years at the time of signing informed consent. For Japan only: Male or female, age equal to or above 20 years at the time of signing informed consent
- Diagnosed with type 2 diabetes mellitus
- HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive)
- Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed-dose drug combination) with a stable dose of metformin (equal to or above 1500 mg or maximum tolerated dose) or a SU for at least 90 days prior to the day of screening. All medications in compliance with current local label
Who cannot join
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice)
- Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed
- Subjects with alanine aminotransferase above 2.5 x upper normal limit
- Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative
- History or presence of pancreatitis (acute or chronic)
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- History of diabetic ketoacidosis
- Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
- Subjects presently classified as being in New York Heart Association Class IV
- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- Renal impairment measured as estimated Glomerular Filtration Rate value of eGFR below 60 ml/min/1.73 m^2 as defined by KDIGO 2012 classification using isotope dilution mass spectrometry for serum creatinine measured at screening
- Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation
- Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed
Trial locations and contacts
72 sites in 7 countries.
72 sites in 7 countries
United States43 sites
Novo Nordisk Investigational Site
Albany, New York, 12206
Novo Nordisk Investigational Site
Andalusia, Alabama, 36420
Novo Nordisk Investigational Site
Anniston, Alabama, 36207
Novo Nordisk Investigational Site
Arlington, Texas, 76012-4637
Novo Nordisk Investigational Site
Austin, Texas, 78745
Novo Nordisk Investigational Site
Baltimore, Maryland, 21204
Novo Nordisk Investigational Site
Beaver, Pennsylvania, 15009
Novo Nordisk Investigational Site
Charlotte, North Carolina, 28207
Novo Nordisk Investigational Site
Charlotte, North Carolina, 28226
Novo Nordisk Investigational Site
Chesapeake, Virginia, 23321
Novo Nordisk Investigational Site
Dallas, Texas, 75208
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Edgewater, Florida, 32132
Novo Nordisk Investigational Site
Gastonia, North Carolina, 28054
Novo Nordisk Investigational Site
Glendale, Arizona, 85308
Novo Nordisk Investigational Site
Greenville, North Carolina, 27834
Novo Nordisk Investigational Site
Houston, Texas, 77081
Novo Nordisk Investigational Site
Hutchinson, Kansas, 67502-1131
Novo Nordisk Investigational Site
Irving, Texas, 75061-2210
Novo Nordisk Investigational Site
Jefferson City, Missouri, 65109
Novo Nordisk Investigational Site
Kinston, North Carolina, 28501
Novo Nordisk Investigational Site
La Jolla, California, 92037
Novo Nordisk Investigational Site
Lawrenceville, Georgia, 30046
Novo Nordisk Investigational Site
Lexington, Kentucky, 40503
Novo Nordisk Investigational Site
Lincoln, California, 95648
Novo Nordisk Investigational Site
Little Rock, Arkansas, 72211
Novo Nordisk Investigational Site
Maitland, Florida, 32751-4422
Novo Nordisk Investigational Site
McMurray, Pennsylvania, 15317
Novo Nordisk Investigational Site
Morehead City, North Carolina, 28557-4346
Novo Nordisk Investigational Site
Murray, Utah, 84123
Novo Nordisk Investigational Site
Norman, Oklahoma, 73069
Novo Nordisk Investigational Site
Northridge, California, 91325
Novo Nordisk Investigational Site
Olympia, Washington, 98502
Novo Nordisk Investigational Site
Phoenix, Arizona, 85037
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15243
Novo Nordisk Investigational Site
Shavano Park, Texas, 78231
Novo Nordisk Investigational Site
Smithtown, New York, 11787
Novo Nordisk Investigational Site
Sugar Land, Texas, 77479
Novo Nordisk Investigational Site
Tempe, Arizona, 85283
Novo Nordisk Investigational Site
Troy, Michigan, 48098
Novo Nordisk Investigational Site
Victoria, Texas, 77901
Novo Nordisk Investigational Site
West Seneca, New York, 14224
Novo Nordisk Investigational Site
Woodstock, Georgia, 30189-4255
Canada8 sites
Novo Nordisk Investigational Site
Brampton, Ontario, L6S 0C6
Novo Nordisk Investigational Site
Brampton, Ontario, L6T 0G1
Novo Nordisk Investigational Site
Edmonton, Alberta, T6H 2L4
Novo Nordisk Investigational Site
Etobicoke, Ontario, M9R 4E1
Novo Nordisk Investigational Site
Smiths Falls, Ontario, K7A 4W8
Novo Nordisk Investigational Site
Toronto, Ontario, M5T 3L9
Novo Nordisk Investigational Site
Waterloo, Ontario, N2J 1C4
Novo Nordisk Investigational Site
Winnipeg, Manitoba, R3E 3P4
Norway7 sites
Novo Nordisk Investigational Site
Hamar, 2317
Novo Nordisk Investigational Site
Hoenefoss, 3515
Novo Nordisk Investigational Site
Namsos, 7801
Novo Nordisk Investigational Site
Olso, 0953
Novo Nordisk Investigational Site
Oslo, 0176
Novo Nordisk Investigational Site
Skedsmokorset, NO-2020
Novo Nordisk Investigational Site
Stavanger, 4005
Russia5 sites
Novo Nordisk Investigational Site
Barnaul, 656045
Novo Nordisk Investigational Site
Novosibirsk, 630099
Novo Nordisk Investigational Site
Saint Petersburg, 191119
Novo Nordisk Investigational Site
Saint Petersburg, 194354
Novo Nordisk Investigational Site
Saint Petersburg, 194358
Austria4 sites
Novo Nordisk Investigational Site
Saint Stefan, 8511
Novo Nordisk Investigational Site
Vienna, 1030
Novo Nordisk Investigational Site
Vienna, 1060
Novo Nordisk Investigational Site
Vienna, 1130
Japan4 sites
Novo Nordisk Investigational Site
Kanagawa, 232-0064
Novo Nordisk Investigational Site
Nagakute-shi, Aichi, 480-1195
Novo Nordisk Investigational Site
Suita-shi, Osaka, 565-0853
Novo Nordisk Investigational Site
Tokyo, 160-0008
About this study
Official title: Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus. A 30-week Randomised, Double-blind, Placebo-controlled Trial
This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. Subjects will remain on their pre-trial medication.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- Semaglutide, Placebo
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Semaglutide, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks
PlaceboDrug
Semaglutide placebo, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Not described Receives: Drug: Semaglutide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change from baseline (week 0) in HbA1c was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: 1) the last dose of trial product + 7 days or 2) initiation of rescue medication.
Measured: Week 0, week 30
Secondary outcomes (57)
Change in Body Weight (kg)
Change from baseline (week 0) in body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: Week 0, week 30
Change in Fasting Plasma Glucose (FPG)
Change from baseline (week 0) in FPG was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: Week 0, week 30
Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean 7-point Profile
Change from baseline (week 0) in mean of the SMPG, 7-point profile was evaluated at week 30. Mean 7-point profile (the area under the profile) was calculated using the trapezoidal method and divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period. Participants measured their plasma glucose at 7 different time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime.
Measured: Week 0, week 30
Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean Post Prandial Increment (Over All Meals)
Change from baseline (week 0) in mean post prandial increment (over all meals) in the SMPG, 7-point profile was evaluated at week 30. The mean increment over all meals was derived as the mean of all available meal increments. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: Week 0, week 30
Change in Fasting Blood Lipid, Total Cholesterol
Change from baseline (week 0) in total cholesterol (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: Week 0, week 30
Change in Fasting Blood Lipid, Low-density Lipoprotein (LDL) Cholesterol
Change from baseline (week 0) in LDL (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: Week 0, week 30
Change in Fasting Blood Lipid, High-density Lipoprotein (HDL) Cholesterol
Change from baseline (week 0) in HDL (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: Week 0, week 30
Change in Fasting Blood Lipid, Triglycerides
Change from baseline (week 0) in triglycerides (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: Week 0, week 30
Change in Body Weight (%)
Percent (%) change from baseline (week 0) in body weight (measured in kilogram (kg)) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: Week 0, week 30
Change in Body Mass Index
Change from baseline (week 0) in body mass index (BMI) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. BMI was calculated as 'body weight in kg/(height in meters) x (height in meters)'.
Measured: Week 0, week 30
Change in Waist Circumference
Change from baseline (week 0) in waist circumference was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: Week 0, week 30
Change in Systolic Blood Pressure
Change from baseline (week 0) in systolic blood pressure was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: Week 0, week 30
Change in Diastolic Blood Pressure
Change from baseline (week 0) in diastolic blood pressure was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: Week 0, week 30
Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains
Change from baseline (week 0) in patient reported outcome (PRO) questionnaire, SF-36v2TM was evaluated at week 30. The SF-36v2™ questionnaire was used to assess the overall health related quality of life of participants. This questionnaire contains 36 items and measures the individual overall health related quality of life on 8 domains: 1) Physical functioning, 2) Role functioning, 3) Bodily pain, 4) General health, 5) Vitality, 6) Social functioning, 7) Role emotional and 8) Mental health. Each item is scored on a scale from 1 to either 2, 3, 5, or 6; each item score is then converted to a scale of 0-100, representing the percentage of total possible score achieved and with higher scores indicating a higher health status; items on the same scale are then averaged to obtain the 8 scale scores. Physical component summary (PCS) includes domains 1-4 and mental component summary (MCS) includes domains 5-8. Higher PCS and MCS scores on a scale of 0-100 indicate a higher health status.
Measured: Week 0, week 30
Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately
Change from baseline (week 0) in PRO questionnaire, DTSQ was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. The DTSQ measures satisfaction with diabetes treatment. The DTSQ consists of 8 items evaluating 6 aspects of treatment satisfaction and 2 perceived recent event rates of hyperglycemia/hypoglycemia. Each item is scored on a 7- point Likert scale ranging from 0 (very dissatisfied) to 6 (very satisfied). Items evaluating 6 aspects (items 3-8) of treatment satisfaction are summed to produce a total treatment satisfaction score; DTSQ status total scores range from 0-36, with higher scores indicating greater satisfaction; the perceived frequency of hyperglycemia/hypoglycemia items are scored separately, with lower scores indicating better perceived blood glucose control.
Measured: Week 0, week 30
HbA1c Below 7.0% (53 mmol/Mol)
Percentage of participants with HbA1c below 7.0% (53 mmol/mol) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: After 30 weeks
HbA1c Equal to or Below 6.5% (48 mmol/Mol)
Percentage of participants with HbA1c equal to or below 6.5% (48 mmol/mol) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: After 30 weeks
Weight Loss Equal to or Above 3%
Percentage of participants with weight loss equal to or above 3% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: After 30 weeks
Weight Loss Equal to or Above 5%
Percentage of participants with weight loss equal to or above 5% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: After 30 weeks
Weight Loss Equal to or Above 10%
Percentage of participants with weight loss equal to or above 10% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: After 30 weeks
HbA1c Below 7.0% (53 mmol/Mol) Without Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain
Percentage of participants with HbA1c below 7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain from their baseline (week 0) body weight was evaluated at week 30. Severe or blood glucose (BG)-confirmed symptomatic hypoglycaemia: an episode that was severe according to the American Diabetes Association (ADA) classification or confirmed by a plasma glucose (PG) value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: After 30 weeks
HbA1c Reduction Equal to or Above 1%-Point
Percentage of participants with HbA1c reduction equal to or above 1%-point was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: After 30 weeks
HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 3%
Percentage of participants with HbA1c reduction equal to or above 1%-point and weight loss equal to or above 3% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: After 30 weeks
HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 5%
Percentage of participants with HbA1c reduction equal to or above 1%-point and weight loss equal to or above 5% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: After 30 weeks
HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 10%
Percentage of participants with HbA1c reduction equal to or above 1%-point and weight loss equal to or above 10% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.
Measured: After 30 weeks
Number of Treatment-emergent Adverse Events (TEAEs)
A TEAE was defined as an event that has onset date (or increase in severity) during the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 42 days.
Measured: Week 0 - week 30
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 42 days. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or confirmed by a PG value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Measured: Week 0 - week 30
Change in Haematology: Haemoglobin
Change from baseline (week 0) in haemoglobin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Change in Haematology: Haematocrit
Change from baseline (week 0) in haematocrit was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Change in Haematology: Thrombocytes
Change from baseline (week 0) in thrombocytes was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Change in Haematology: Erythrocytes
Change from baseline (week 0) in erythrocytes was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Change in Haematology: Leucocytes
Change from baseline (week 0) in leucocytes was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Change in Biochemistry: Amylase
Change from baseline (week 0) in amylase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Change in Biochemistry: Lipase
Change from baseline (week 0) in lipase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Change in Biochemistry: Alkaline Phosphatase
Change from baseline (week 0) in alkaline phosphatase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Change in Biochemistry: Alanine Aminotransferase
Change from baseline (week 0) in alanine aminotransferase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Change in Biochemistry: Aspartate Aminotransferase
Change from baseline (week 0) in aspartate aminotransferase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Change in Biochemistry: Total Bilirubin
Change from baseline (week 0) in total bilirubin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Change in Biochemistry: Albumin
Change from baseline (week 0) in albumin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Change in Biochemistry: Calcium (Total)
Change from baseline (week 0) in albumin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Change in Biochemistry: Potassium
Change from baseline (week 0) in potassium was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Change in Biochemistry: Sodium
Change from baseline (week 0) in sodium was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Change in Biochemistry: Bicarbonate
Change from baseline (week 0) in bicarbonate was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Change in Biochemistry: Estimated Glomerular Filtration Rate (eGFR)
Change from baseline (week 0) in eGFR was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Change in Biochemistry: Creatinine
Change from baseline (week 0) in creatinine was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Change in Calcitonin
Change from baseline (week 0) in calcitonin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Change in Pulse
Change from baseline (week 0) in pulse rate was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Change in Electrocardiogram
Electrocardiogram (ECG) results are presented for week 0 (baseline) and week 30. ECG finding are presented as percentage of participants with normal, abnormal non-clinically significant (NCS) and abnormal clinically significant (CS) ECG values. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 42 days.
Measured: Week 0, week 30
Change in Physical Examination: General Appearance
Physical examination (general appearance) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week -2, week 30
Change in Physical Examination: Central and Peripheral Nervous System
Physical examination (central and peripheral nervous system) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week -2, week 30
Change in Physical Examination: Cardiovascular System
Physical examination (cardiovascular system) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week -2, week 30
Change in Physical Examination: Gastrointestinal System Including Mouth
Physical examination (gastrointestinal system including mouth) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week -2, week 30
Change in Physical Examination: Skin
Physical examination (skin) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week -2, week 30
Change in Physical Examination: Respiratory System
Physical examination (respiratory system) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week -2, week 30
Change in Physical Examination: Lymph Node Palpation
Physical examination (lymph node palpation) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week -2, week 30
Change in Physical Examination: Thyroid Gland
Physical examination (thyroid gland) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week -2, week 30
Change in Fundoscopy
Fundoscopy results for both left and right eyes are presented for week 0 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.
Measured: Week 0, week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start15 Mar 2017
- Primary completion4 Jul 2018
- Study completion6 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086330
- Sponsor's protocol ID
- NN9535-4269
- Other IDs
- 2016-000904-27, U1111-1180-1213, JapicCTI-173542, 2016
- Acronym
- SUSTAIN 9
- Status last verified
- Jul 2021
- First submitted
- 14 Mar 2017
- Last updated
- 2 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Zinman B, Bhosekar V, Busch R, Holst I, Ludvik B, Thielke D, Thrasher J, Woo V, Philis-Tsimikas A. Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2019 May;7(5):356-367. doi: 10.1016/S2213-8587(19)30066-X. Epub 2019 Mar 1.
PubMed 30833170
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus. A 30-week Randomised, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03086330
- Acronym / sponsor ID
- SUSTAIN 9 / NN9535-4269
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 6 Aug 2018 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Posted 20 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. Subjects will remain on their pre-trial medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: Semaglutide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- Male or female, above or equal to 18 years at the time of signing informed consent. For Japan only: Male or female, age equal to or above 20 years at the time of signing informed consent
- Diagnosed with type 2 diabetes mellitus
- HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive)
- Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed-dose drug combination) with a stable dose of metformin (equal to or above 1500 mg or maximum tolerated dose) or a SU for at least 90 days prior to the day of screening. All medications in compliance with current local label
Key exclusion criteria (13 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice)
- Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed
- Subjects with alanine aminotransferase above 2.5 x upper normal limit
- Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideSemaglutide, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks | Drug | Semaglutide |
| PlaceboSemaglutide placebo, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks | Drug | Placebo |
Primary outcome
Change in HbA1c
Time frame: Week 0, week 30
Change from baseline (week 0) in HbA1c was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: 1) the last dose of trial product + 7 days or 2) initiation of rescue medication.
57 secondary outcomes
Change in Body Weight (kg)
Time frame: Week 0, week 30
Change in Fasting Plasma Glucose (FPG)
Time frame: Week 0, week 30
Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean 7-point Profile
Time frame: Week 0, week 30
Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean Post Prandial Increment (Over All Meals)
Time frame: Week 0, week 30
Change in Fasting Blood Lipid, Total Cholesterol
Time frame: Week 0, week 30
Change in Fasting Blood Lipid, Low-density Lipoprotein (LDL) Cholesterol
Time frame: Week 0, week 30
Change in Fasting Blood Lipid, High-density Lipoprotein (HDL) Cholesterol
Time frame: Week 0, week 30
Change in Fasting Blood Lipid, Triglycerides
Time frame: Week 0, week 30
Change in Body Weight (%)
Time frame: Week 0, week 30
Change in Body Mass Index
Time frame: Week 0, week 30
Change in Waist Circumference
Time frame: Week 0, week 30
Change in Systolic Blood Pressure
Time frame: Week 0, week 30
Change in Diastolic Blood Pressure
Time frame: Week 0, week 30
Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains
Time frame: Week 0, week 30
Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately
Time frame: Week 0, week 30
HbA1c Below 7.0% (53 mmol/Mol)
Time frame: After 30 weeks
HbA1c Equal to or Below 6.5% (48 mmol/Mol)
Time frame: After 30 weeks
Weight Loss Equal to or Above 3%
Time frame: After 30 weeks
Weight Loss Equal to or Above 5%
Time frame: After 30 weeks
Weight Loss Equal to or Above 10%
Time frame: After 30 weeks
HbA1c Below 7.0% (53 mmol/Mol) Without Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain
Time frame: After 30 weeks
HbA1c Reduction Equal to or Above 1%-Point
Time frame: After 30 weeks
HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 3%
Time frame: After 30 weeks
HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 5%
Time frame: After 30 weeks
HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 10%
Time frame: After 30 weeks
Number of Treatment-emergent Adverse Events (TEAEs)
Time frame: Week 0 - week 30
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Time frame: Week 0 - week 30
Change in Haematology: Haemoglobin
Time frame: Week 0, week 30
Change in Haematology: Haematocrit
Time frame: Week 0, week 30
Change in Haematology: Thrombocytes
Time frame: Week 0, week 30
Change in Haematology: Erythrocytes
Time frame: Week 0, week 30
Change in Haematology: Leucocytes
Time frame: Week 0, week 30
Change in Biochemistry: Amylase
Time frame: Week 0, week 30
Change in Biochemistry: Lipase
Time frame: Week 0, week 30
Change in Biochemistry: Alkaline Phosphatase
Time frame: Week 0, week 30
Change in Biochemistry: Alanine Aminotransferase
Time frame: Week 0, week 30
Change in Biochemistry: Aspartate Aminotransferase
Time frame: Week 0, week 30
Change in Biochemistry: Total Bilirubin
Time frame: Week 0, week 30
Change in Biochemistry: Albumin
Time frame: Week 0, week 30
Change in Biochemistry: Calcium (Total)
Time frame: Week 0, week 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30833170Zinman B, Bhosekar V, Busch R, Holst I, Ludvik B, Thielke D, Thrasher J, Woo V, Philis-Tsimikas A. Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2019 May;7(5):356-367. doi: 10.1016/S2213-8587(19)30066-X. Epub 2019 Mar 1.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
72 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 72 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, Canada, Norway, Russia, Austria and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: Week 0, week 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03086330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.